Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia

Innovent Biologics (Suzhou) Co. Ltd.804 enrolled

Overview

IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C) uptake. This study is being done to investigate the effects of IBI306 in Chinese people with non-familial hypercholesterolemia with very high or high cardiovascular risk. This study will see if IBI306 will reduce low density lipoprotein cholesterol (LDL-C) in Chinese people who are taking a certain type of lipid-lowering medication (statins with or without ezetimibe) and whether it causes any side effects

This is a phase 3, multicenter, double-blind, randomized, placebo-controlled study of IBI306 in Chinese non-familial hypercholesterolemia Subjects with very high or high cardiovascular risk. A total of around 600 subjects who meet admission criteria will be randomized and receive one of the two dose levels of IBI306 or matching placebo: 450mg Q4W, or 600mg Q6W. The double blind period for both groups will be 48 weeks. The study will last 52 weeks

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

804

Conditions

Hypercholesterolemia

Interventions

IBI306 450mg SC Q4WDRUG

Subjects will receive IBI306 450mg every 4 weeks subcutaneously.

Placebo SC Q4WDRUG

Subjects will receive placebo every 4 weeks subcutaneously.

IBI306 600mg SC Q6WDRUG

Subjects will receive IBI306 600mg every 6 weeks subcutaneously.

Placebo SC Q6WOTHER

Subjects will receive placebo every 6 weeks subcutaneously.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Males and females ≥ 18 to ≤ 75 years of age 2. Diagnosis of hypercholesterolemia 3. LDL cholesterol ≥ 70 mg/dl (1.8mmol/L) 4. Very high or high cardiovascular risk 5. TG≤500 mg/dL(5.64 mmol/L) Exclusion criteria: 1. Diagnosis of HoFH or HeFH 2. Uncontrolled hypertension 3. Uncontrolled hyperthyroidism or hypothyroidism 4. Severe renal dysfunction 5. Known sensitivity to any of the products to be administered during dosing

Outcomes

Primary Outcomes

Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48

Time frame: Week 48

Secondary Outcomes

The percent of subjects with LDL-C reduction no less than 50% from baseline

Time frame: Week 48

The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)

Time frame: Week 48

The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline

Time frame: Week 48

Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes